1. Field of the Invention
This invention relates to topical formulations for treatment of damaged skin, such as irradiated skin in combination with wound treatment. In particular, the invention relates to topical formulations useful for the treatment of skin damaged by the harmful effects of radiation and radioactive substances, such as used in the treatment of cancer or exposure to the sun, open sores, wounds and abrasions.
2. Description of the Prior Art
According to the American Cancer Society's Cancer Facts and FIGS.-1991, at the current rate, about 76 million Americans now living will eventually have cancer. It will strike three of four families. Cancer strikes at any age. It kills more children of age 1 to 14 in the United States than any other disease and occurs more frequently with age. Based on current medical technology over half of these cancer patients will undergo some form of radiation therapy.
In the 1930's, less than one in five was alive at least five years after treatment. In the 1940's, it was one in four, and in the 1960's, it was one in three. Today about 440,000 Americans, or 4 of 10 patients who get cancer, will be alive five years after diagnosis. The gain from 1 in 3 to 4 in 10 represents about 77,000 persons this year.
The primary goal of the medical community has been to prolong the life of cancer patients. Until recently, and in relation to the growing number of cancer patients that can expect to survive five years or more, the quality of life of the cancer patient has received attention.
The onset of radiodermatitis as a result of irradiation in cancer patients is well documented. It is characterized by congestive or exudative redness of the skin caused by hyperthermia. Therefore, there is a need for substances effective for treating irradiated skin damage or radiodermatitis.
The topical use of anti-inflammatory agents to alleviate radiodermatitis is known. Such compositions contain combinations of one or more steroidal anti-inflammatories, non-steroidal anti-inflammatories, as well as "natural" anti-inflammatories, such as an extract of aloe vera.
The "greying of America" is also well documented. People are living longer and have expectations for a quality life as well as a long life. People afflicted with long term illness run the risk of getting bed sores, pressure sores and a myriad of skin irritations due to incontinence.
Looking at the treatment figures for pressure ulcers, just a small part of the entire market, one can quickly see that there is a need to develop products that will effectively treat patients with long term illnesses.
As part of a study using AMA data on admissions to acute hospitals to derive the number of patients at risk of pressure ulcers, the statistics and forecasts are as follows:
TABLE 1 ______________________________________ Pressure Ucleration in U.S. Hospitals PATIENTS (1000's) 1989 1990 1995 2000 2005 ______________________________________ STAGE 1 539 547 596 656 718 STAGE 2 779 790 861 947 1037 STAGE 3 180 182 199 219 239 STAGE 4 180 182 199 219 239 TOTAL 1677 1701 1853 2040 2233 ______________________________________
Therefore, there is a need for a substance which will reduce bed sores or ulceration.
The bradykininase activity or ability to reduce swelling which is present in cold-processed aloe vera, with yellow sap and aloin removed, is clinically proven when used in high concentrations. See, K. Fujita, R. Teradair, and T. Nagatsu, Biochem. Pharm., Vol. 25, 205, 1976.
However, some extracts of aloe vera have been found to be toxic and the applicability of aloe vera for treatment of skin disorders is not generally accepted or understood. Winters et al. conducted a study to determine the toxicity of yellow sap and aloin on human skin cells (fibroblast) that were obtained from human foreskin. The cells were grown in MEM supplemented with 5 percent human serum. The yellow sap was tested at 1, 10, 15, and 30 percent and compared to untreated control cells. There was a 100 percent cell kill recorded at all levels when yellow sap was applied to fibroblast. I. Danhof, Ph.D., M.D. and B. McAnalley, Ph.D., "Stabilized aloe vera: Effect on human skin cells", D&CI, 4-5, 105-106, (August 1983).
Several prior art patents disclose cosmetic/therapeutic formulations including aloe vera. DeNavarre, "Non-irritating Antiperspirant" U.S. Pat. No. 4,302,443 discloses the use of aloe vera to prevent irritation. DeNavarre does not claim to use fresh aloe vera that has been filleted with the outer rind, yellow sap and aloin removed by a cold-process to produce a substantially anthraquinone-free fillet that is ground, homogenized and processed into a stable aloe vera extract. There is also no combination in DeNavarre with allantoin and lavender essential oil, or any claim for the treatment of irradiated skin, open sores, wounds or abrasions.
Mihalovits, "Cosmetic Facial Preparation Containing Aloe Vera" U.S. Pat. No. 4,369,180 discloses the use of aloe vera in combination with cornstarch or cosmetic clay, albumin, allantoin, vitamin A, vitamin D2, and vitamin E. Mihalovits also does not claim to use fresh aloe vera that has been filleted with the outer rind, yellow sap and aloin removed by a cold-process to produce a substantially anthraquinone-free fillet that is then ground, homogenized and processed into a stable aloe vera extract. Mihalovits teaches the use of allantoin, but only in formulations at 0.5% by weight, which is significantly less than the present invention, and makes no claims for the use of lavender essential oil. Mihalovits further makes no claims as a treatment for irradiated skin, open sores, wounds or abrasions.
Millard, "Skin Treatment Preparation" U.S. Pat. No. 4,505,902 discloses a formulation which uses aloe vera juice in combination with mineral oil, apricot kernel oil, avocado oil, and cod liver oil. Millard does not claim to use fresh aloe vera that has been filleted with the outer rind, yellow sap and aloin removed by a cold-process to produce a substantially anthraquinone-free fillet that is then ground, homogenized and processed into a stable aloe vera extract. There is no teaching to combine it with allantoin and lavender essential oil, and no claims as a treatment for irradiated skin, open sores, wounds or abrasions.
Trenzeluk, "Skin Therapeutic Mixture Containing Aloe Vera Extract" U.S. Pat. No. 4,857,328 discloses a formulation using the dried leaves of the aloe vera plant as the therapeutic agent for the treatment of acne, psoriasis, burns, pimples, blackheads, and open sores. Trenzeluk directs the use of dried leaves of the aloe vera plant and does not claim to use fresh aloe vera that has been filleted with the outer rind, yellow sap and aloin removed by a cold-process to produce a substantially anthraquinone-free fillet that is then ground, homogenized and processed into a stable aloe vera extract. There is not teaching relating to the combination with allantoin and lavender essential oil.
Therefore, it is an object of the present invention to provide a phase stable topical formulation, which uses the extract from cold-processed aloe vera gel, with yellow sap and aloin removed, combined with allantoin and lavender essential oil, the use of which will provide treatment of radiodermatitis and the chronic effects of radiation exposure without interfering with the radiation therapy, treatment of open sores, wounds or abrasions.
It is also an object of the present invention to provide a phase stable cleansing composition, which uses the extract from cold-processed aloe vera gel, with yellow sap and aloin removed, combined with allantoin and lavender essential oil, the use of which will provide a method for relieving the deleterious effects of radiation without interfering with the radiation therapy, treatment of open sores, wounds or abrasions.